Tea and Forearm Blood Flow

Vascular Function Clinical Trial

Official title:

Forearm Blood Flow Response to Acute Consumption of Black Tea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328339
• Other study ID #: REF-BEV-1797
• Status: Completed
• Phase: N/A
• First received: December 19, 2014
• Last updated: August 28, 2015
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The study will explore the benefit of tea for microcirculation. Subjects will consume tea ar a placebo matched for taste and appearance in a blinded cross over design.

Description:

Epidemiological studies indicate that regular consumption of black tea reduces the risk of cardiovascular diseases. Tea consumption can result in improvements in endothelial function of conduit arteries as measured by flow mediated dilation.

Less is known however about its effects in other vascular beds. The study will test the hypothesis that tea affects endothelial function in the muscle microcirculation. This will be done by assessment of forearm blood flow using venous occlusion plethysmography after consumption of black tea against or placebo in a randomised, full cross-over study in 20 healthy middle-aged to elderly subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Males and post menopausal (> 1 years) females

• Aged = 45 and = 75 years

• Body mass index (BMI) of = 18.0 and = 35.0 kg/m2

• Judged to be in good health on the basis of medical history, physical examination and routine laboratory tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, glucose, highly sensitive C-reactive protein).

• Normal blood coagulation as assessed by routine lab tests

Exclusion Criteria:

• Strenuous exercise > 2 hours per week. Strenuous exercise is defined as exercise which induces sweating and causes sufficient breathlessness to limit conversation

• Current smoker or has stopped smoking less than 6 months before start of study

• Self reported alcohol intake of > 21 units/week)

• Established cardiovascular disease or clinically significant arrhythmia

• Diabetes mellitus

• Blood pressure > 160/100 mmHg

• Taking medication that might affect endothelial function (as judged by the PI)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vascular Function

Intervention

Other:
• Tea
Black tea infusion equivalent to approximately 530 mg total polyphenols expressed as gallic acid equivalents
• Placebo
Placebo matched to tea with respect to taste and appearance

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	Radboud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forearm blood flow response to acetylcholine	Does tea ingestion change mean forearm blood flow response to acetylcholine when compared to placebo	During acetylcholine infusion 120-140 min after first tea/placebo intake	No
Secondary	Forearm blood flow response to sodium nitropusside	Does tea ingestion change mean forearm blood flow response to sodium nitropusside when compared to placebo	During sodium nitropusside infusion 170-190 min after first tea/placebo intake	No
Secondary	Forearm blood flow response to L-NMMA	Does tea ingestion change mean forearm blood flow response to L-NG-monomethyl Arginine (L-NMMA) when compared to placebo	During L-NMMA infusion 220-240 min after first tea/placebo intake	No